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Volume 16, Number 15
May 02, 2011
CATT findings: Lucentis, Avastin equal
Visian ICL V4 granted CE mark
VEGF Trap-Eye yields positive results for CRVO
Iris Pharma, Opia Technologies form license agreement
FDA deems AzaSite ad “misleading”

CATT findings: Lucentis, Avastin equal

Cancer drug Avastin (bevacizumab, Genentech, San Francisco) is as efficacious as Lucentis (ranibizumab, Genentech) in treating neovascular age-related macular degeneration (AMD), according to initial results from the Comparison of AMD Treatments Trials (CATT), the National Eye Institute (NEI, Bethesda, Md.) said in a press release. NEI reported results from the first year of the 2-year study.
In the multicenter, single-masked trial, researchers randomly assigned 1,208 patients with neovascaular AMD to receive intravitreal injections of Lucentis or Avastin on either a monthly schedule or as needed. The primary outcome was the mean change in visual acuity at 1 year. In the study, both drugs provided beneficial outcomes to patients with between 25% and 34% of affected eyes improving substantially and more than 90% of affected eyes avoiding any further loss of vision.
"Over 250,000 patients are treated each year for AMD, and a substantial number of them receive Avastin. Given the lack of efficacy data regarding Avastin for AMD treatment, the NEI had an obligation to patients and clinicians to conduct this study," Paul A. Sieving, M.D., director of the NEI, said in the release.
Given monthly, Avastin used off-label helped patients gain 8.0 letters, while Lucentis helped them gain 8.5 letters. When dosed on a PRN schedule, Avastin showed a 5.9 letter gain and Lucentis a 6.8 letter gain.
“The initial results of the CATT study affirm the position of the American Academy of Ophthalmology that both Lucentis and Avastin should be available for the treatment of AMD,” said David W. Parke II, M.D., chief executive officer of AAO, in a press release.
The 1-year results were published in the New England Journal of Medicine and were presented in full at the Association for Research in Vision and Ophthalmology meeting this week.

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Visian ICL V4 granted CE mark

STAAR Surgical (Monrovia, Calif.) received CE mark approval for the Visian Implantable Collamer Lens (ICL) V4c design, the company said in a press release.
The V4c design uses a port in the center of the ICL optic designed to optimize the flow of fluid within the eye, eliminating the need for a YAG peripheral iridotomy prior to implantation, STAAR said. The V4c model has been approved in the –0.5 D to –18.0 D ranges and +0.5 cylinder power to +6.0 for the toric ICL models.

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VEGF Trap-Eye yields positive results for CRVO

Well over half the patients implanted with the VEGF Trap-Eye (Regeneron Pharmaceuticals, Tarrytown, N.Y./Bayer Healthcare, Berlin) gained at least 15 letters of acuity from baseline to week 24, the companies announced in a press release. Results from the Phase III study dubbed Galileo validated those found in an earlier study (Copernicus). Both studies evaluated VEGF Trap-Eye for the treatment of macular edema due to central retinal vein occlusion (CRVO).
In Galileo, 104 patients received VEGF Trap-Eye 2 mg and 68 received placebo. The primary endpoint at week 24 was achieved: 60.2% of patients receiving monthly VEGF Trap-Eye 2 mg gained at least 15 letters of vision from baseline, compared to 22.1% in the sham group (P<.0001). The key secondary endpoint of the study was also met: Patients receiving VEGF Trap-Eye gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (P<.0001).
VEGF Trap-Eye is a fully human fusion protein, consisting of soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related placental growth factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron plans to submit a regulatory application for marketing approval in CRVO in the U.S. in the second half of 2011, and Bayer Healthcare intends to seek regulatory approval in Europe in 2012, the companies said in the release.

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Iris Pharma, Opia Technologies form license agreement

Iris Pharma (La Gaude, France) and Opia Technologies (Paris) have entered into a long-term license agreement to develop Opia’s EyePrim in animal studies, the companies announced. As part of this agreement, Iris Pharma has an exclusive license to use the EyePrim device to perform ocular surface biopsies of the living eye in clinical research. The EyePrim device uses a conjunctival impression technique that collects the most superficial layer of epithelial cells from the conjunctival mucosa.

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FDA deems AzaSite ad “misleading”

The U.S. FDA issued a letter to Inspire Pharmaceuticals (Raleigh, N.C.) stating that an advertisement for Inspire’s product AzaSite (azithromycin ophthalmic solution) is “false and misleading,” the FDA said on its website.
The letter cited an advertisement for AzaSite that “broadens the indication” of the drug and “omits and minimizes important risks” associated with the use of AzaSite. Specifically, the FDA noted the ad’s claims that AzaSite “can restore a healthy ocular surface by delivering significant anti-inflammatory and anti-microbial effects directly to the site of the problem.” In addition, the ad omitted risks of anaphylaxis and hypersensitivity with systemic use of azithromycin. The FDA recommended that Inspire immediately discontinue the ad.

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RESEARCH BRIEFS

  • Hyperopic LASIK performed with an IntraLase femtosecond laser (Abbott Medical Optics, Santa Ana, Calif.) appears to yield better refractive results at 3 months follow-up than the M2 microkeratome (Moria, Antony, France), according to a study. Raquel Gil-Cazorla and colleagues in Spain retrospectively evaluated patients who underwent LASIK to correct hyperopia using the 60 kHz IntraLase femtosecond laser, compared to age- and refraction-matched patients whose surgery was performed using the Moria M2 microkeratome. Visual and refractive results of 144 eyes (72 in each group) were assessed 3 months after surgery and compared between the two groups. The mean pre-op sphere was +3.45±1.0 D in the IntraLase group and +3.18±1.3 D in the M2 group. Three months after surgery, the mean residual sphere in the IntraLase group was +0.44±0.6 D compared to +0.72±0.8 D in the M2 group (P=.02). Uncorrected VA was 0.89±0.2 in the IntraLase group vs. 0.80±0.2 in the M2 group (P=.04). Best spectacle corrected VA was 0.96±0.2 in the IntraLase group vs. 0.92±0.2 in the M2 group (P=.2). The researchers found no significant disparities in safety between the groups. The study is published in the American Journal of Ophthalmology.
  • Face-to-face upright seated positioning is a beneficial approach to cataract surgery for patients unable to lie flat or undergo general anesthesia, according to a study. Richard M.H. Lee and colleagues in Norwich, U.K., conducted a case series on 28 patients who underwent 32 procedures by one physician between June 2004 and July 2010. Most of the patients were unable to lie flat due to a combination of health problems, classified as mainly neurological (five eyes), mainly orthopedic (13 eyes), mainly cardiac/respiratory (12 eyes), or psychological (two eyes). The American Society of Anesthesiologists grade of physical states for all patients was either III or IV. Face-to-face positioning was used to perform phacoemulsification and implantation of a foldable IOL in all patients. In 31 of 32 of the procedures, surgery was completed according to plan (97%). In one case, there was a posterior capsule rupture with a dropped nucleus, and a vitrectomy under general anesthesia was necessary to complete surgery. No patient experienced post-op complications, and visual recovery was uneventful. The study is published in the Journal of Cataract and Refractive Surgery.

NEW PRODUCT BRIEFS

  • Volk Optical (Mentor, Ohio) added the Condensing Lens Assembly (CLA) to its recently launched Merlin Surgical System, the company said in a press release. The CLA offers lens positioning that is system-directed via a footpedal or the device’s lens positioning unit (LPU). When the LPU is swung into the surgical field, bringing the Volk lens into position, the CLA automatically places the condensing lens in the optical pathway “to provide crisp retinal views during vitreoretinal surgery.” 
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EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor

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Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS•ASOA. Mention of products or services does not constitute an endorsement by ASCRS•ASOA.

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